This medical device is classified as class IIb according to the European Medical Device Directive in force. It bears the CE marking. Notifed Body: IMQ 0051. This medical device is intended for dental care and is reserved for health care professional; it is notreimbursed by health insurance agencies.
This equipment has been designed and manufactured in keeping with a quality system certified EN ISO 13485. Carefully read the user manual available at www.degotzen.com - Manufactured and Distributed ® by de Götzen.